COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, AND TENOFOVIR

(koe BIK i stat, EL vi TEG ra vir, EM trye SYE ta been, and ten OF oh vir) Brand: Stribild

What is the most significant information I must know about Stribild?

Stribild is a complete treatment and must not be used in combination with another antiviral medications.

Many drugs can interact with Stribild and some must not be used at the same time, especially: alfuzosin, cisapride, lovastatin, simvastatin, oral midazolam, triazolam, pimozide, rifampin, sildenafil (for treating pulmonary arterial hypertension), St. John's wort, or ergot medication (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

• Stribild can reason severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• Some people develop lactic acidosis while taking this medication. Early symptoms may get worse over time and this condition can be fatal. Get abnormal medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cool feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, quick or uneven heart course, dizziness, or feeling very weak or weary.

If you have hepatitis B you may develop liver symptoms after you stop taking Stribild, even months after stopping. Your doctor may want to check your liver function for different months after you stop using this medication.

What is Stribild (cobicistat, elvitegravir, emtricitabine, and tenofovir)?

• Cobicistat, elvitegravir, emtricitabine and tenofovir are antiviral drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in the body. HIV causes acquired immunodeficiency syndrome (AIDS).

• Stribild (cobicistat, elvitegravir, emtricitabine, and tenofovir) is a combination medication used to treat HIV in adults who have never taken HIV medicines till. Stribild is not a cure for HIV or AIDS.

• Stribild may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking Stribild?

Stribild is a complete treatment and must not be used in combination with another antiviral medications, especially medicines that contain adefovir, emtricitabine, lamivudine, or tenofovir: Atripla, Combivir, Complera, Emtriva, Epivir, Epzicom, Hepsera, Trizivir, Truvada, or Viread.

• You must not take Stribild if you are allergic to cobicistat, elvitegravir, emtricitabine, or tenofovir.

Some medicines can interact with Stribild and must not be used at the same time. Your doctor may need to change your treatment plan if you use any of the next drugs:

· alfuzosin;

· lovastatin, simvastatin;

· oral midazolam, triazolam;

· pimozide;

· rifampin;

· sildenafil (Revatio, for treating pulmonary arterial hypertension);

· St. John's wort; or

· ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine.

• To create certain Stribild is safety for you, speak your doctor if you have:

· liver or kidney disease;

· osteopenia (low bone mineral density); or

· if you also have hepatitis B infection.

• Some people taking Stribild develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver malady, and in people who have taken HIV/AIDS medicine for a long time. Conversation with your doctor about your risk.

• FDA pregnancy category B. Stribild is not expected to be deleterious to an unborn child. However, HIV can be passed to your child if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Speak your doctor if you are pregnant or plan to become pregnant during treatment.

• If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to estimate any effects of Stribild on the baby.

• Women with HIV or AIDS must not breast feed a child. Even if your child is born without HIV, the virus may be passed to the child in your breast milk.

• Do not give this medicine to anyone under 18 years old without medical advice.

How must I take Stribild?

• Stribild is generally taken once for day. Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Take with food.

Do not change your doze or medicine schedule without your doctor's advice. Each face with HIV or AIDS must stay under the care of a doctor.

• While using Stribild, your blood may need to be tested often. Your bone density and kidney or liver function may also need to be tested.

• Use this medication regularly to get the most benefit. Get your prescription refilled till you run out of medication completely.

• Store in the original container at room temperature, away from moisture and heat. Hold the bottle tightly closed when not in use.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using Stribild.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking Stribild?

Taking this medicine will not prevent you from passing HIV to another people. Do not have unprotected sex or share razors or toothbrushes. Conversation with your doctor about safety ways to prevent HIV transmission during sex. Sharing drug or medication needles is never safety, even for a healthy person.

• Avoid taking an antacid within 2 hours till or after you take Stribild. Some antacids can create it harder for your body to absorb Stribild.

What are the possible side effects of Stribild?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Some people develop lactic acidosis while taking Stribild. Early symptoms may get worse over time and this condition can be fatal. Get abnormal medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cool feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, quick or uneven heart course, dizziness, or feeling very weak or weary.

• Call your doctor at once if you have:

· few or no urinating;

· swelling, rapid weight gain;

· heighten thirst and urination, loss of appetite, weakness, constipation;

· signs of liver hurt - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• Stribild may magnify your risk of determined infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Stribild. Speak your doctor if you have:

· signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

· chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

· cool sores, sores on your genital or anal area;

· rapid heart course, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

· trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

· swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

• General side effects may include:

· headache, strange dreams;

· mild diarrhea. mild nausea; or

· changes in the shape or location of body thick (especially in your arms, legs, person, neck, breasts, and waist).

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect cobicistat, elvitegravir, emtricitabine, and tenofovir?

Stribild can harm your kidneys. This effect is heighten when you also use determined another medicines, including: antivirals, chemotherapy, injected antibiotics, medication for bowel disorders, medication to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

• Much drugs can interact with Stribild. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with Stribild, especially:

· atorvastatin;

· colchicine;

· dexamethasone;

· digoxin;

· salmeterol;

· an antibiotic such as clarithromycin;

· an antidepressant;

· antifungal medication--itraconazole, ketoconazole, voriconazole;

· hormonal contraception (birth control pills or skin patches);

· heart rhythm medicine--amiodarone, disopyramide, flecainide, mexiletine, propafenone, quinidine, and others;

· medication to prevent organ transplant rejection;

· a sedative or sleep medicine, such as Valium, Ambien, and others;

· seizure medication--carbamazepine, clonazepam, ethosuximide, oxcarbazepine, phenytoin;

· sildenafil (Viagra) or another erectile dysfunction medicines; or

· tuberculosis medication--rifabutin, rifapentine.

This list is not complete and much another drugs can interact with Stribild. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about Stribild (cobicistat, elvitegravir, emtricitabine, and tenofovir).

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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